FDA 483 - Nellcor Puritan Bennett Mexico, S.A. de C.V. - November 05, 2004

An FDA inspection of Nellcor Puritan Bennett Mexico, S.A. de C.V. in Tijuana B.C. revealed critical deficiencies in their medical device manufacturing processes. The firm failed to adequately monitor and control bioburden on CapnoProbe sensors during production. This lapse led to significant bacterial contamination, including Burkholderia cepacia and Stenotrophamonas maltaphilia, and was associated with possible consumer injuries.